drugset / Trial / NCT06175494
A Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Phase 3
Unknown
4800 enrolled
WestVac Biopharma Co., Ltd.
WestVac Biopharma (Guangzhou) Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5. This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study with two cohorts, i.e. the immuno-bridging observational cohort and the efficacy observational cohort, aims to evaluate the efficacy, safety, and immunogenicity of booster vaccination with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the prevention of SARS-CoV-2 infection in a population of 18 years of age and older.
Timeline
- Start
- 2023-12-19
- Primary completion
- 2024-07-31
- Completion
- 2025-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) | Vaccine | — | — |
| Comparator | Recombinant COVID-19 Variant Vaccine (Sf9 Cell) | Vaccine | — | — |